Manager, Commercial Manufacturing QA Small Molecules
vor 6 Monaten
Overview:
SUMMARY
The Manager, Commercial Manufacturing QA is responsible for the Quality oversight of commercial manufacturing activities associated with Drug substance, Drug Product and Britestock.
He/She assures compliance of assigned registered products throughout their lifecycle, with cGMP requirements and registration files.
He/She is responsible of assigned product quality management as well as vendor oversight and performance management.
**Responsibilities**:
- Manage the day-to day quality oversight of assigned Commercial CMOs and contract labs including compliance and performance monitoring,
- Assures compliance of products by creating, approving and maintaining Product monographs,
- Perform Batch Record Reviews and decide on batch dispositions,
- Prepare and conduct Quality and Business Review meetings with the assigned Commercial CMOs
- Provide QA oversight of Stability Programs for Registered Products,
- Maintain and control the Product Batch Records filling and databases,
- Ensure implementation of Continued Process Verification at assigned Commercial CMOs,
- Manage and approve internal and external deviations, OOS and related investigations,
- Manage and monitor implementation of internal and external change controls,
- Manage and monitor implementation of internal and external CAPAs,
- Coordinate the collection of APQR data and lead the issuance of Annual Product Quality Reviews,
- Establish and maintain Quality and Technical Agreements with assigned Commercial CMOs,
- Contribute to the maintenance of Incyte Quality Management System with a focus on the analytical related SOPs,
- Perform external and internal audits according to Incyte audit program,
- Support the RA-CMC group for regulatory submissions and follow-ups,
- Ensure inspection readiness at assigned Commercial CMOs,
- Participate to the inspection readiness of the Incyte Biosciences International Site
- Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and analytical testing and ensure implementation as applicable,
- Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements,
- Stay current with the applicable regulations and promote Quality across the Incyte organization,
- Cooperate with the Commercial Supply Chain, RA-CMC, Analytical Operations and Regulatory Affairs functions in matters relating to Commercial Products.
- Act as back-up of other Commercial Manufacturing QA Managers
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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